Cardiovascular DiseasesPhase 2NCT00000615
Girls Health Enrichment Multi-Site Studies (GEMS)
A Phase 2 study testing diet, reducing in people with Cardiovascular Diseases and Heart Diseases, run by Stanford University.
Trial summary
To develop and test interventions to prevent obesity by decreasing weight gain during the high-risk transitional period from pre-puberty to puberty in African-American girls who are at high risk for developing obesity. Read more about this study
- Who is it for?
- Ages 8 to 10 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Obesity
- What is being tested?
- diet, reducing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 1999to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- Women only
- No healthy volunteers
- Child
African-American girls, age 8-10 years.
About this study
To develop and test interventions to prevent obesity by decreasing weight gain during the high-risk transitional period from pre-puberty to puberty in African-American girls who are at high risk for developing obesity.
Read the detailed description
BACKGROUND:
The high prevalence of obesity in Black women may be a contributing factor to their higher mortality from cardiovascular disease and higher prevalence of diabetes and hypertension compared with white and Hispanic women. Although Hispanic women also exhibit high prevalence of obesity, mortality from heart disease is less than for Black or white women and mortality from diabetes is less than for Black women.
The increased prevalence of obesity in Black females is present during childhood, and the prevalence of obesity is increasing faster in Black girls than in white girls. Recent data from the third National Health and Nutrition Examination Survey (NHANES III) showed that during preadolescence, age 6-11 years, 30.7 percent of Black girls, compared with 22.0 percent of white girls, were overweight. Furthermore, over the past 30 years the prevalence of obesity in this preadolescent age group has increased 150 percent in Black girls compared with 40 percent in white girls. The prevalence of obesity in the adolescent age of 12 to 17 years is similarly high, at 29.9 percent in Black girls compared with 20.7 percent in white girls. The 35 percent increase in obesity over the past 30 years is similar in the preadolescent and adolescent age groups for white girls, but for Black girls the increase is greater in the younger age group (150 percent more prevalent) than in the older age group (80 percent increase) .
The Special Emphasis Panel (SEP) on Intervention Studies in Children and Adolescents to Prevent Cardiovascular Disease was convened in September 1997 to review the efficacy and effectiveness of interventions to prevent and improve known cardiovascular disease risk factors in children and adolescents and to develop recommendations for future preventive intervention studies. The initiative was developed in response to recommendations of the SEP. The RFA was released in April 1998.
DESIGN NARRATIVE:
The Girl's health Enrichment Multi-site Studies (GEMS) is a collection of studies designed to develop and test interventions to prevent excessive weight gain by African-American girls as they enter and proceed through puberty. The research is being conducted as four inter-dependent, clinical trials. They are "inter-dependent" in the sense that they are considering similar study populations, following similar follow-up schedules and use a "core" set of evaluation procedures. Nonetheless, GEMS is not a "multi-center clinical trial" in the usual sense - each field center is evaluating its own intervention (and corresponding control). As a result, each study will have high internal validity and will be designed and analyzed as a study in its own right.
In Phase I, several distinct and separate interventions were developed. Interventions addressed diet, physical activity, and psychosocial and familial influences. There were four participating centers in Phase I, including the University of Memphis, Stanford University, the University of Minnesota, and Baylor College of Medicine. The coordinating center was located at George Washington University.
In Phase II, individual clinical trials will be supported to test the efficacy of interventions developed in Phase I. Although the interventions developed by each field center will be unique, the centers will collaborate to standardize key measurements, outcomes, and main analysis methods. The Memphis Field Center will conduct a full-scale two year, randomized, controlled clinical trial for weight gain prevention among 300 high risk, preadolescent African American girls and their parents. Body mass index is the primary endpoint. Secondary endpoints include dietary intake, physical activity, and psychosocial variables. The Stanford Field Center will conduct a two-arm parallel group, randomized controlled trial to test the efficacy of an after school dance program and a family-based intervention to reduce television, videotape, and video game use to reduce weight gain among 260 African American preadolescent girls. An active placebo group will receive an information-based community health education intervention. Interventions will last for two years. Body mass index is the primary outcome measure.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Being tested
- diet, reducing
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet, reducingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startAug 1999
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Thomas Robinson, Stanford University
- Investigators
- Tom Baronowski, Baylor College of MedicineRobert Klesges, University of MemphisThomas Robinson, Stanford UniversityJames Rochon, George Washington UniversityMary Story, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000615
- Sponsor's protocol ID
- 118
- Other IDs
- U01HL062663
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 1999
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matheson DM, Hanson KA, McDonald TE, Robinson TN. Validity of children's food portion estimates: a comparison of 2 measurement aids. Arch Pediatr Adolesc Med. 2002 Sep;156(9):867-71. doi: 10.1001/archpedi.156.9.867.
PubMed 12197792Ford BS, McDonald TE, Owens AS, Robinson TN. Primary care interventions to reduce television viewing in African-American children. Am J Prev Med. 2002 Feb;22(2):106-9. doi: 10.1016/s0749-3797(01)00410-x.
PubMed 11818179Robinson TN. Television viewing and childhood obesity. Pediatr Clin North Am. 2001 Aug;48(4):1017-25. doi: 10.1016/s0031-3955(05)70354-0.
PubMed 11494635Kumanyika SK, Obarzanek E, Robinson TN, Beech BM. Phase 1 of the Girls health Enrichment Multi-site Studies (GEMS): conclusion. Ethn Dis. 2003 Winter;13(1 Suppl 1):S88-91.
PubMed 12713214Story M, Sherwood NE, Obarzanek E, Beech BM, Baranowski JC, Thompson NS, Owens AS, Mitchell M, Rochon J. Recruitment of African-American pre-adolescent girls into an obesity prevention trial: the GEMS pilot studies. Ethn Dis. 2003 Winter;13(1 Suppl 1):S78-87.
PubMed 12713213Kumanyika SK, Story M, Beech BM, Sherwood NE, Baranowski JC, Powell TM, Cullen KW, Owens AS. Collaborative planning for formative assessment and cultural appropriateness in the Girls health Enrichment Multi-site Studies (GEMS): a retrospection. Ethn Dis. 2003 Winter;13(1 Suppl 1):S15-29.
PubMed 12713208Obarzanek E, Pratt CA. Girls health Enrichment Multi-site Studies (GEMS): new approaches to obesity prevention among young African-American girls. Ethn Dis. 2003 Winter;13(1 Suppl 1):S1-5.
PubMed 12713206Treuth MS, Sherwood NE, Butte NF, McClanahan B, Obarzanek E, Zhou A, Ayers C, Adolph A, Jordan J, Jacobs DR, Rochon J. Validity and reliability of activity measures in African-American girls for GEMS. Med Sci Sports Exerc. 2003 Mar;35(3):532-9. doi: 10.1249/01.MSS.0000053702.03884.3F.
PubMed 12618587Baranowski T, Baranowski JC, Cullen KW, Thompson DI, Nicklas T, Zakeri IE, Rochon J. The Fun, Food, and Fitness Project (FFFP): the Baylor GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S30-9.
PubMed 12713209Rochon J, Klesges RC, Story M, Robinson TN, Baranowski T, Obarzanek E, Mitchell M. Common design elements of the Girls health Enrichment Multi-site Studies (GEMS). Ethn Dis. 2003 Winter;13(1 Suppl 1):S6-14.
PubMed 12713207Story M, Sherwood NE, Himes JH, Davis M, Jacobs DR Jr, Cartwright Y, Smyth M, Rochon J. An after-school obesity prevention program for African-American girls: the Minnesota GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S54-64.
PubMed 12713211Sherwood NE, Taylor WC, Treuth M, Klesges LM, Baranowski T, Zhou A, Pratt C, McClanahan B, Robinson TN, Pruitt L, Miller W. Measurement characteristics of activity-related psychosocial measures in 8- to 10-year-old African-American girls in the Girls Health Enrichment Multisite Study (GEMS). Prev Med. 2004 May;38 Suppl:S60-8. doi: 10.1016/j.ypmed.2003.12.030.
PubMed 15072860Treuth MS, Sherwood NE, Baranowski T, Butte NF, Jacobs DR Jr, McClanahan B, Gao S, Rochon J, Zhou A, Robinson TN, Pruitt L, Haskell W, Obarzanek E. Physical activity self-report and accelerometry measures from the Girls health Enrichment Multi-site Studies. Prev Med. 2004 May;38 Suppl:S43-9. doi: 10.1016/j.ypmed.2003.01.001.
PubMed 15072858Taylor WC, Baranowski T, Klesges LM, Ey S, Pratt C, Rochon J, Zhou A. Psychometric properties of optimism and pessimism: results from the Girls' Health Enrichment Multisite Studies. Prev Med. 2004 May;38 Suppl:S69-77. doi: 10.1016/j.ypmed.2003.10.015.
PubMed 15072861Cullen KW, Watson K, Himes JH, Baranowski T, Rochon J, Waclawiw M, Sun W, Stevens M, Slawson DL, Matheson D, Robinson TN. Evaluation of quality control procedures for 24-h dietary recalls: results from the Girls Health Enrichment Multisite Studies. Prev Med. 2004 May;38 Suppl:S14-23. doi: 10.1016/j.ypmed.2003.10.014.
PubMed 15072855
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Girls Health Enrichment Multi-Site Studies (GEMS)
- ClinicalTrials.gov ID
- NCT00000615
- Acronym / sponsor ID
- 118
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 1999
- Study completion
- Nov 2006
- First posted
- 28 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To develop and test interventions to prevent obesity by decreasing weight gain during the high-risk transitional period from pre-puberty to puberty in African-American girls who are at high risk for developing obesity.
Detailed description
BACKGROUND:
The high prevalence of obesity in Black women may be a contributing factor to their higher mortality from cardiovascular disease and higher prevalence of diabetes and hypertension compared with white and Hispanic women. Although Hispanic women also exhibit high prevalence of obesity, mortality from heart disease is less than for Black or white women and mortality from diabetes is less than for Black women.
The increased prevalence of obesity in Black females is present during childhood, and the prevalence of obesity is increasing faster in Black girls than in white girls. Recent data from the third National Health and Nutrition Examination Survey (NHANES III) showed that during preadolescence, age 6-11 years, 30.7 percent of Black girls, compared with 22.0 percent of white girls, were overweight. Furthermore, over the past 30 years the prevalence of obesity in this preadolescent age group has increased 150 percent in Black girls compared with 40 percent in white girls. The prevalence of obesity in the adolescent age of 12 to 17 years is similarly high, at 29.9 percent in Black girls compared with 20.7 percent in white girls. The 35 percent increase in obesity over the past 30 years is similar in the preadolescent and adolescent age groups for white girls, but for Black girls the increase is greater in the younger age group (150 percent more prevalent) than in the older age group (80 percent increase) .
The Special Emphasis Panel (SEP) on Intervention Studies in Children and Adolescents to Prevent Cardiovascular Disease was convened in September 1997 to review the efficacy and effectiveness of interventions to prevent and improve known cardiovascular disease risk factors in children and adolescents and to develop recommendations for future preventive intervention studies. The initiative was developed in response to recommendations of the SEP. The RFA was released in April 1998.
DESIGN NARRATIVE:
The Girl's health Enrichment Multi-site Studies (GEMS) is a collection of studies designed to develop and test interventions to prevent excessive weight gain by African-American girls as they enter and proceed through puberty. The research is being conducted as four inter-dependent, clinical trials. They are "inter-dependent" in the sense that they are considering similar study populations, following similar follow-up schedules and use a "core" set of evaluation procedures. Nonetheless, GEMS is not a "multi-center clinical trial" in the usual sense - each field center is evaluating its own intervention (and corresponding control). As a result, each study will have high internal validity and will be designed and analyzed as a study in its own right.
In Phase I, several distinct and separate interventions were developed. Interventions addressed diet, physical activity, and psychosocial and familial influences. There were four participating centers in Phase I, including the University of Memphis, Stanford University, the University of Minnesota, and Baylor College of Medicine. The coordinating center was located at George Washington University.
In Phase II, individual clinical trials will be supported to test the efficacy of interventions developed in Phase I. Although the interventions developed by each field center will be unique, the centers will collaborate to standardize key measurements, outcomes, and main analysis methods. The Memphis Field Center will conduct a full-scale two year, randomized, controlled clinical trial for weight gain prevention among 300 high risk, preadolescent African American girls and their parents. Body mass index is the primary endpoint. Secondary endpoints include dietary intake, physical activity, and psychosocial variables. The Stanford Field Center will conduct a two-arm parallel group, randomized controlled trial to test the efficacy of an after school dance program and a family-based intervention to reduce television, videotape, and video game use to reduce weight gain among 260 African American preadolescent girls. An active placebo group will receive an information-based community health education intervention. Interventions will last for two years. Body mass index is the primary outcome measure.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 8 to 10 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet, reducing | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Background: PubMed 12197792Matheson DM, Hanson KA, McDonald TE, Robinson TN. Validity of children's food portion estimates: a comparison of 2 measurement aids. Arch Pediatr Adolesc Med. 2002 Sep;156(9):867-71. doi: 10.1001/archpedi.156.9.867.
- Background: PubMed 11818179Ford BS, McDonald TE, Owens AS, Robinson TN. Primary care interventions to reduce television viewing in African-American children. Am J Prev Med. 2002 Feb;22(2):106-9. doi: 10.1016/s0749-3797(01)00410-x.
- Background: PubMed 11494635Robinson TN. Television viewing and childhood obesity. Pediatr Clin North Am. 2001 Aug;48(4):1017-25. doi: 10.1016/s0031-3955(05)70354-0.
- Background: PubMed 12713214Kumanyika SK, Obarzanek E, Robinson TN, Beech BM. Phase 1 of the Girls health Enrichment Multi-site Studies (GEMS): conclusion. Ethn Dis. 2003 Winter;13(1 Suppl 1):S88-91.
- Background: PubMed 12713213Story M, Sherwood NE, Obarzanek E, Beech BM, Baranowski JC, Thompson NS, Owens AS, Mitchell M, Rochon J. Recruitment of African-American pre-adolescent girls into an obesity prevention trial: the GEMS pilot studies. Ethn Dis. 2003 Winter;13(1 Suppl 1):S78-87.
- Background: PubMed 12713208Kumanyika SK, Story M, Beech BM, Sherwood NE, Baranowski JC, Powell TM, Cullen KW, Owens AS. Collaborative planning for formative assessment and cultural appropriateness in the Girls health Enrichment Multi-site Studies (GEMS): a retrospection. Ethn Dis. 2003 Winter;13(1 Suppl 1):S15-29.
- Background: PubMed 12713206Obarzanek E, Pratt CA. Girls health Enrichment Multi-site Studies (GEMS): new approaches to obesity prevention among young African-American girls. Ethn Dis. 2003 Winter;13(1 Suppl 1):S1-5.
- Background: PubMed 12618587Treuth MS, Sherwood NE, Butte NF, McClanahan B, Obarzanek E, Zhou A, Ayers C, Adolph A, Jordan J, Jacobs DR, Rochon J. Validity and reliability of activity measures in African-American girls for GEMS. Med Sci Sports Exerc. 2003 Mar;35(3):532-9. doi: 10.1249/01.MSS.0000053702.03884.3F.
- Background: PubMed 12713209Baranowski T, Baranowski JC, Cullen KW, Thompson DI, Nicklas T, Zakeri IE, Rochon J. The Fun, Food, and Fitness Project (FFFP): the Baylor GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S30-9.
- Background: PubMed 12713207Rochon J, Klesges RC, Story M, Robinson TN, Baranowski T, Obarzanek E, Mitchell M. Common design elements of the Girls health Enrichment Multi-site Studies (GEMS). Ethn Dis. 2003 Winter;13(1 Suppl 1):S6-14.
- Background: PubMed 12713211Story M, Sherwood NE, Himes JH, Davis M, Jacobs DR Jr, Cartwright Y, Smyth M, Rochon J. An after-school obesity prevention program for African-American girls: the Minnesota GEMS pilot study. Ethn Dis. 2003 Winter;13(1 Suppl 1):S54-64.
- Background: PubMed 15072860Sherwood NE, Taylor WC, Treuth M, Klesges LM, Baranowski T, Zhou A, Pratt C, McClanahan B, Robinson TN, Pruitt L, Miller W. Measurement characteristics of activity-related psychosocial measures in 8- to 10-year-old African-American girls in the Girls Health Enrichment Multisite Study (GEMS). Prev Med. 2004 May;38 Suppl:S60-8. doi: 10.1016/j.ypmed.2003.12.030.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Baronowski
Baylor College of Medicine
Robert Klesges
University of Memphis
Thomas Robinson
Stanford University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing diet, reducing in people with Cardiovascular Diseases and Heart Diseases, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000615, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.